Valley Fever Study

SPECIFIC AIMS

The objectives of this project are as follows:

1. Demonstrate the efficacy and predictability of a natural bio-specifically designed orally applied formula
when used by itself.
2. Demonstrate that this formula can safely and effectively replace and or work in concert with any of the
three accepted antifungal medications currently used for VF (ketaconazole, fluconazole & itraconazole.)
3. Reduce existent titers by a minimum of 50% in six months and by consistent decline
4. Reduce or eliminate symptoms and minimize side-effects.
5. Enhance immunological defense through the use of the alternative therapy.
6. Track and improve the following biomarkers on serum reports associated with this disease: albumin,
globulins, calcium, liver enzymes (i.e. aspartate aminotransferase and alanine aminotransferase), and
five major white blood cell types (neutrophils, lymphocytes, monocytes, eosinophils and basophils)

RESEARCH PLAN: HOLISTIC FORMULA

The design platform is as follows:

-A nutritional powder that is added to the food for broad and general metabolic support
-An encapsulated companion pill (dietary supplement) that specifically targets the disease activity
-A two-step combination that will exert the same anti-fungal activity as conventional therapy by interrupting the metabolism of the lipid-based fungal cell membrane. Through this mechanism, fungal propagation is negated.
- Strengthens first and second line defenses for other disease and viral application.
- Nutritionally enhances blood proteins, the complement system, nitrogen balance and toxin reduction.
- Consists of high level human-grade/food-grade ingredients to ensure quality and potency and maximize absorption and utilization.
- Contains a transport system to optimize the oral delivery and ensure greatest absorption.

METHODS

Group 1
-10 participants will be provided with a privately mixed powder formulation to use for 180 days.
-The powders will be commercially available healthcare quality purchased at wholesale and then mixed and encapsulated to distribute to participants.
-To enroll the pet owner must complete a detailed questionnaire, and sign a full waiver and release.
-Health records will be evaluated prior to participation in the study to establish a physiological baseline for safety and potential response to the study.
-Eligible canines must be currently diagnosed with VF by way of a positive cocci screen with immunoglobulin G and M titers of 1:8 to 1:64 and be symptomatic (this was revised).
-Diagnostics and veterinary exam will be performed initially then at 90 days and at 180 days to monitor and record metabolic, physiologic and immunologic changes to include titer fluctuations.
-Subjects can only be on approved medications.
-Study is limited to only medium to large dogs (30 to 80 pounds) again the highest risk category
-Exceptions to these parameters may be made on a case by case basis.
-No Charge

Group 2
-The above parameters
-Exceptions to these parameters may be made on a case by case basis.
-Consulting fee of $275 for 90 days

STUDY CONCLUSION

It is anticipated that by study conclusion a final version of the nutritional formula will be completed and ready for larger scale manufacture and distribution through the veterinary and pet retail networks of the southwest. Preliminary data results will be made available to veterinarians and the results of the study released to the Arizona Veterinary Medical Society and other interested parties for presentation purposes.